Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

 
Docket ID: FDA-2009-D-0461
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Status: OPEN
Docket Details open glossary dialog  
Related RINs: None
Short Title: Draft Guidance for Industry on Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications; Availability
Keyword(s): REMS, Format and Content, mitigation, cder200911, CBER, CDER
Type: Nonrulemaking
Center: CDER
Docket Item Code: D
 

Primary Documents

View All  (4)
Comment Period Closed
Aug 31, 2010 11:59 PM ET
Notice
Posted: 06/17/2010
ID: FDA-2009-D-0461-0040
Comment Period Closed
Dec 30, 2009 11:59 PM ET
Other
Posted: 10/01/2009
ID: FDA-2009-D-0461-0002
Comment Period Closed
Dec 30, 2009 11:59 PM ET
Notice
Posted: 10/01/2009
ID: FDA-2009-D-0461-0001
Comment Period Closed
Other
Posted: 10/21/2010
ID: FDA-2009-D-0461-0068

Supporting Documents

 
The contents of the section were withdrawn at the request of the Food and Drug Administration and the Department of Health and Human Services.

Comments

View All  (64)

71
Comments Received*
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.